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The Efficacy and Optimal Dose of Sufentanil in Patient Controlled Analgesia After Moderate Surgery

NCT02503826 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-21

No results posted yet for this study

Summary

Effective postoperative pain control is essential for patients and inadequate postoperative pain relief can cause mental and psychological sufferings. Despite the growing concern on postoperative pain management, acute postoperative pain is still poorly managed. Though numerous clinical practice guidelines for postoperative pain management have been published throughout the last decades, inadequate pain relief remain a big health care issue. Sufentanil has been used as satisfied pain control drug because of its strong potency of analgesia for a long while. But its use in patient controlled intravenous analgesia (PCIA) has not been clarified. And the dilemma of safety concern and insufficient dosage of analgesic is a common problem. Thus the investigators design this prospective randomized controlled double blinded trial to observe the efficacy and the optimal dose of sufentanil in PCIA in patients underwent moderate surgery for the purpose of providing reference in clinical practice.

Conditions

  • Analgesia, Patient-Controlled
  • Gastrectomy
  • Arthroplasty

Interventions

DRUG

Sufentanil

low dose

DRUG

Sufentanil

moderate dose

DRUG

Sufentanil

high dose

DRUG

Midazolam

Midazolam 2 mg, sufentanil 0.5 mcg/kg, propofol 2 mg/kg, cisatracurium 2 mg/kg for induction, continuous infusion of propofol, remifentanil and cisatracurium to maintain bispectral index (BIS) value between 40 and 60 for maintenance.

DRUG

propofol

DRUG

cisatracurium

Sponsors & Collaborators

  • Second Affiliated Hospital of Xi'an Jiaotong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503826 on ClinicalTrials.gov